Junior CRA - RWLP - Paris based

IQVIA; Paris; On-site; EUR 42,000 - 65,000; Full time

Job summary

IQVIA is seeking a Clinical Research Associate to monitor clinical sites, ensure protocol compliance, and support data integrity for studies. You will perform site visits, manage communications with investigators, and track progress across regulatory submissions and patient recruitment.

The role requires knowledge of GCP/ICH guidelines, strong organizational skills, and ability to work with cross-functional teams. Based in Paris, on-site engagement is expected.

Qualifications

• Bachelor's degree or equivalent in science/health care; CRA training preferred.

Responsibilities

• Perform site monitoring visits (initiation, monitoring, close-out) per scope of work and GCP/ICH guidelines.
• Collaborate with sites to drive and track recruitment plans to meet project needs.
• Administer protocol and study training to sites; maintain regular communication.
• Assess site practices for protocol compliance and regulatory adherence; escalate issues.
• Track regulatory submissions, approvals, recruitment, CRF completion, data queries; support start-up if needed.
• Ensure TMF/ISF documents are filed per GCP/ICH and local requirements.
• Document site management findings and action plans; submit visit reports and follow-up letters.
• Collaborate with study team for project execution support; assist in recruitment planning and site budgeting as applicable.

Skills

Communication

Organizational skills

Problem solving

Time management

Relationship building

Education

Bachelor's degree in scientific discipline or health care

Equivalent combination of education, training and experience

CRA training considered a plus

Tools

MS Word

MS Excel

PowerPoint

iPhone/iPad use (where applicable)

Job description

Job Description Summary

Job Overview

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications

• Bachelor's Degree Degree in scientific discipline or health care preferred. Req
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Some organizations require completion of CRA training program or prior monitoring experience.
• Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.